Drug Development Partner

Developing a product from concept to commercialization requires successful partnership. With over 20 years of experience partnering with global pharmaceutical firms large and small, we understand what it takes to be an effective drug development partner. We pride ourselves on our ability to achieve milestones within set deadlines, provide transparent communication, be adaptable to change, and offer our expertise throughout the process.

Some of Our Partners

Through our services, we can develop products in any therapeutic area in which there is a need. We can form drug development partnerships with organizations focused on aspects such as:

• Post-operative pain
• Oncology
• Joint pain
• Cardiology
• The central nervous system
• Opioid and substance abuse
• Endocrinology

Benefits of Drug Development Partnering with Oakwood

• One-stop shop from R&D formulation development through GMP commercial manufacturing
• Patented microsphere technology allowing tailored release profile from weeks to one year
• Over 20 years of experience encapsulating sustained-release injectables
• Demonstrated lot-to-lot reproducibility with proven scale-up success
• FDA-approved aseptic GMP facility, manufacturing clinical and commercial sterile injectables
• Track record of success with bringing projects from proof of concept to clinical trials
• Strong focus on communication and project management to achieve milestones

Project Management

All work is carried out using project management tools, and is performed on a fixed-fee basis. Once a project is initiated a dedicated team is selected. The typical team includes formulation scientists, analytical chemists, and a project manager. We report on our progress regularly in formal conference calls or face-to-face meetings as often as desired.

Oakwood is completely transparent, and all data is compiled and provided to our clients on a regular basis. Our senior managers are available for consultations at any time. As a drug development partner, we encourage a culture of openness, flexibility, and agility in accomplishing our work on behalf of our clients.

FAQs for Our Drug Development Partnering Process

What manufacturing services do you offer?

We support all phases of long-acting injectable development. When drug development partnering with us, you can take advantage of our range of services, as we can supply:

• Phase I, II, III clinical trial material
• Small-volume sterile injectables
• Commercial products to be utilized in humans or veterinary use
• Class III and IV controlled substances
• Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and more
• Vials with lyophilized or plug stoppers (13 mm and 20 mm openings)

What technology is used to create sterile injectables?

For pharmaceutical production to occur, there must be sterile processing equipment used. It’s common to see electro-steam generators, washer-disinfectors, and autoclaves in the manufacturing process.

What are the benefits of the microsphere technology Chroniject^TM?

We provide innovative technology via our Chroniject^TM that delivers many advantages to your operations. By drug development partnering with us, you’ll reap benefits such as:

• Instant reconstitution with WFI – no special diluent required
• Formulations that are easily scalable
• Rapid development of formulations using small-scale batches
• Excellent stability
• Proven lot-to-lot reproducibility
• Well-controlled process parameters
• Molecule compatibility (small molecules, proteins, peptides)
• Flexible release durations from one week to one year

What are the reasons for developing a long-acting injectable using microspheres?

Microspheres can be tailored to a specific application and API, leading to better pharmacokinetics, stability and bioavailability. Their use can also lead to improved intellectual property and life-cycle management properties. By choosing Oakwood Labs as your drug development partner for long-acting injectables, you can benefit from improved patient compliance, lower dosage requirements, and anatomical targeting.

Choose Oakwood Labs as Your Drug Development Partner

We understand that in order to develop a viable sustained-release drug, you need a successful partnership. We can be the effective drug development partner you require and offer our expertise throughout the entire process. Contact us today to get started!